510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Izenimplant Co., Ltd.

Pyeongtaek-si Gyeonggi, KR

IZENIMPLANT CO., LTD. appears in FDA device records in Pyeongtaek-si Gyeonggi, KR. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 8 510(k) clearances for Izenimplant Co., Ltd. between 2022 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Izenimplant Co., Ltd., by decision year
YearClearances
20221
20233
20242
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253334ZENEX Implant System_Short (R-System)DZESubstantially Equivalent
K252585ZENEX Implant System_R-SystemDZESubstantially Equivalent
K240560ZENEX Implant System_LongDZESubstantially Equivalent
K232170Ti Link AbutmentNHASubstantially Equivalent
K233163ZENEX Implant System_ShortDZESubstantially Equivalent
K231557ZENEX FreeMilling & CCM Cast AbutmentNHASubstantially Equivalent
K230630ZENEX Implant System_NarrowDZESubstantially Equivalent
K211090ZENEX Implant SystemDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Izenimplant Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30180972393018097239IZENIMPLANT CO., LTD.1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si Gyeonggi 17703 KR2026
30314931193031493119IZENIMPLANT CO., LTD.30, Jeongnamsandan 1-gil, Jeongnam-myeon, Hwaseong-si Gyeonggi 18514 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain